MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO2; CAROTID SINUS LEAD

Model Number	1036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Salivary Hypersecretion (4486); Voice alteration (4906)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A barostim system was implanted on (b)(6) 2025 and last titrated from 3.0 to 4.0ma on (b)(6) 2025.Since implant, the patient experienced an overactive salivary gland and lip numbness on the right side of their mouth causing a lisp.The surgeon expected the symptoms to resolve; no intervention was planned.Barostim therapy was increased to 6.0ma on (b)(6) 2025.
Additional Manufacturer Narrative
While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was the implant procedure.In the opinion of cvrx's physician consultant, it was possible the hypoglossal (cn12) and glossopharyngeal nerves (cn 9) were affected by the implant.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id#: (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h11.Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025 with a longitudinal incision with a bifurcation in a normal location.Since implant, the patient experienced an overactive salivary gland and lip numbness on the right side of their mouth causing a lisp.The surgeon expected the symptoms to resolve, no intervention was planned.Barostim therapy was increased to 6.0ma on (b)(6) 2025.As of (b)(6) 2025, the patient had started feeling some better.As of (b)(6) 2025, the patient had been doing better and starting to recover.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h11.Cvrx id# (b)(4).
Event or Problem Description
A barostim system was implanted on (b)(6) 2025 with a longitudinal incision with a bifurcation in a normal location.Since implant, the patient experienced an overactive salivary gland and lip numbness on the right side of their mouth causing a lisp.The surgeon expected the symptoms to resolve; no intervention was planned.Barostim therapy was increased to 6.0ma on (b)(6) 2025.As of (b)(6) 2025, the patient had started feeling some better.As of (b)(6) 2025, the patient had been doing better and starting to recover.As of (b)(6) 2026, the patient was still experiencing a lisp but was feeling much better and did not want to change any barostim settings.

• Brand Name: BAROSTIM NEO2
• Common Device Name: CAROTID SINUS LEAD
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis 55445
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis 55445
• MDR Report Key: 23649481
• Report Number: 3007972010-2025-00120
• Device Sequence Number: 4824407
• Product Code: DSR
• UDI-Device Identifier: 00859144004463
• UDI-Public: (01)00859144004463(17)270306
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1036
• Device Catalogue Number: 100065-212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 01/25/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/19/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White